CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Respiratory support: NAVA -NIV and PC-NIVother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04000568
NCT04000568N/ACompleted
CompareCT.gov

Breathing Pattern Variability in Preterm Infants: Effect of Non-invasive Neurally Adjusted Ventilatory Assist (NAVA-NIV) Versus Nasal Intermittent Positive Pressure Ventilation (PC-NIV), a Crossover Study

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico·observational·Posted Jun 27, 2019·Updated Mar 14, 2023

In Brief

An observational study evaluating Respiratory support: NAVA -NIV and PC-NIV for Neonatal Respiratory Distress Syndrome and Prematurity. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The current study is a crossover trial, aiming at evaluating the effect of NAVA -NIV compared to Nasal Intermittent Positive Pressure Ventilation (PC-NIV) at the same level of peak inspiratory pressure, in terms of: breath-by-breath variability of tidal breathing amplitude, variability of the other breathing patterns; lung mechanics; gas exchange; rate of episodes of apnea; bradycardia and desaturations; respiratory asynchrony and comfort, in preterm infants \< 37+0 weeks+days post-menstrual age.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Respiratory Distress Syndrome, Prematurity
CountriesItaly
CollaboratorsPolitecnico di Milano

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 27, 2019
Enrollment StartMay 2, 2019
Primary CompletionSep 30, 2022
Study CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.0 years ago

Interventions

Respiratory support: NAVA -NIV and PC-NIVother

The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order